MATFLAGELLIN

NEP Control Flagellin- PyroMAT^® System MAT

Non-endotoxin pyrogen control of flagellin for use in monocyte activation test

• Synonym(s): NEP, NEP Control
• UNSPSC Code: 41116130
• eCl@ss: 32160606
• NACRES: NA.24

Properties

• Assay: ≥95% (SDS-PAGE)
• Quality Level: 400
• usage: sufficient for 10 tests
• feature: Non-endotoxin pyrogen control of flagellin for use in monocyte activation test
• manufacturer/tradename: PyroMAT^®
• application(s): pharmaceutical; pyrogen testing
• compatibility: configured for PyroDetect System; configured for PyroMAT^® System
• shipped in: cooler
• storage temp.: −20°C
• suitability: pyrogenic bacteria

Description

General description

The PyroMAT^® System uses cryopreserved Mono-Mac-6 (MM6) human monocytic cells as a source of monocytes. The response to a full range of pyrogens, including endotoxins and non-endotoxin pyrogens (NEPs)is determined by the measurement of interleukin-6 (IL-6) produced by the Mono-Mac-6 cells using ELISA.
NEP control flagellin is a preparation of flagellin from Salmonella typhimurium and supplied in a lyophilized form. Flagellin is a non-endotoxin pyrogen (NEP) that activates the TLR5 receptor of monocytes and can be used as a positive control with the PyroMAT^® System (Monocyte Activation Test for pyrogen detection).

Specificity

TLR-5 agonist

Application

NEP control of flagellin can be used as a positive control with the PyroMAT^® System. It is to be used for Product Specific Validation (PSV) and routine testing to show that the system can detect non-endotoxin pyrogen contaminants in pharmaceutical products.

Features and Benefits

Endotoxin-free product at concentration of use in MAT Purity: ≥ 95% (SDS-PAGE)

Storage and Stability

Store unopened vials at -20°C
Do not use unopened vials after expiration date
Store resuspended aliquots at -20°C
Shelf life of aliquots can be found on the technical datasheet

Legal Information

PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety Information

• Storage Class Code: 13 - Non Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable